Kornimate/medical-research-clean huggingface dataset:
post-market clinical follow-up study with magnetic resonance imaging conditional guide wire

Conditions: Congenital Heart Defect

Summary: this is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.the procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.

this is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety of a guide wire conditional for use in magnetic resonance imaging and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence. the guidewire is used to access the patients central circulatory system and in particular for the introduction and exact placement of a pressure catheter to measure the pressure gradient over the aortic arch. the procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.patients need to have a body weight over 40 kg and the introduction of a 5 french catheter should be possible. the primary endpoint is the measurement of procedural success, defined as successful insertion, steerability and visibility in mri, in the absence of device related adverse events such as damage to vessel wall. in addition structural integrity of the instruments is to be assessed.

Eligibility criteria:
inclusion criteria: * patients with clinical indication for cardiac magnetic resonance and conventional diagnostic catheterisation * patients with body weight of \> 40 kg in which the introduction of an introducer of \> 5 french is possible. * subject provided written informed consent using the approved consent form or in case of a minor the subject provided written assent and its legal guardian provided written informed consent. exclusion criteria: * major surgery in the last 42 days * history of irreversible bleeding disorder * contraindication to cardiac magnetic resonance * contraindications to guidewire procedures, such as evidence of active infection * women of child-bearing potential who cannot provide a negative pregnancy test * chronic total occlusion.

Keywords: magnetic resonance spectroscopy aortic arch
mitral valve management during septal myectomy

Conditions: Hypertrophic Cardiomyopathy

Summary: objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

there is pilot prospective randomised study comparing immediate and early results of additional subvalvular mitral apparatus intervention versus additional alfieri stich in patients scheduled to septal myectomy for symptomatic obstructive cardiomyopathy. patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. if patients were suitable for both surgical techniques, they were randomized to alfieri stich or secondary cord cutting. all surgeons were experienced at least 50 related procedures.

Eligibility criteria:
inclusion criteria: * hypertrophic obstructive cardiomyopathy * left ventricle outflow tract gradient \> 50 mm hg at rest * systolic anterior motion mediated mitral regurgitation exclusion criteria: * intrinsic valvular heart disease * coronary artery disease * aortic disease

Keywords: septal myectomy hypertrophic cardiomyopathy
a comparison of morbidity between patients with pulmonary atresia with intact ventricular septum and uni- or biventricular circulation

Conditions: Pulmonary Atresia With Intact Ventricular Septum

Summary: the goal of this observational study is to compare patients with pulmonary atresia with intact ventricular septum (pa-ivs) with univentricular circulation to patients with the same heart defect but that has a biventricular circulation in regards to mortality, quality of life, comorbidity, cardiac function, and work capacity. the main questions the study aims to answer are: • do mortality, quality of life, comorbidity, cardiac function, and work capacity differ between patients with pa-ivs who have univentricular and biventricular circulation? participants will be asked to answer a quality of life questionnaire. the investigators will also inquire with a sample size of the research subjects (based on place of residence) about their participation in a series of examinations (ergo-spirometry to assess work capacity, transthoracic echocardiogram, magnetic resonance of the heart and blood sampling to assess cardiac function and cardiac health).


Eligibility criteria:
inclusion criteria: * individuals born with pulmonary atresia with intact ventricular septum (pa-ivs) who are 15 years or older at the start of the study. * regarding the mortality variable, research subjects who have died after the age of 15 years old will be included. exclusion criteria: individuals born with pulmonary atresia with intact ventricular septum who are younger than 15 years old at the start of the study.
stabilizing mandibular overdentures with a single implant placed in the canine region of the preferred chewing side

Conditions: Completely Edentulous Patients

Summary: the investigators are evaluating the use of a single implant to stabilize complete dentures in the lower jaw, in the canine region of the preferred chewing side. they are conducting this study to determine whether this treatment concept gives satisfactory results, and how it compares with the standard position in the center of the lower jaw.


Eligibility criteria:
inclusion criteria: * informed consent signed by the subject * age ≥ 60 years * edentulous and wearing sufficient complete maxillary and mandibular dentures or ones that can be rendered sufficient via a reline and/or renewal of the prosthetic teeth * healed edentulous mandible (minimum 6-8 weeks since last extraction in the anterior zone (4-4) and one year in the posterior zone (5-8)) * physical status asa1 and asa2 exclusion criteria: * contraindications to the medical devices used, e.g. known hypersensitivity or allergy * vulnerable subjects * enrollment of the investigator, his/her family members, employees and other dependent persons * known or suspected non-compliance, drug or alcohol abuse * inability to perform adequate oral hygiene * inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, parkinson etc. of the subject (dementia: clock-drawing test score ≤ 5) * surgical risk factors such as, but not limited to, uncontrolled diabetes, immunosuppression, radiation, chemotherapy, or antiresorptive medication (ex. bisphosphonates) * heavy smoking habit: \>20 cig/d * reported severe bruxism or clenching habits, clinically present oro-facial pain * depression: geriatric depression scale \> 9 * xerostomia: ssfr ≤ 0.7ml/min * ridge dimensions \<6 mm (width) by 10 mm (height) in the canine or midline area * ridge defects requiring bone augmentation procedures
evaluation of the association between osteoporosis and postural balance in postmenopausal women

Conditions: Postural Balance

Summary: the incidence of osteoporosis has been increasing, as have fractures resulting from falls.

the overall objective of this study is to evaluate bipodal postural balance in postmenopausal women with and without lumbar osteoporosis. the specific objective is to determine the relationship between the degree of thoracic kyphosis and dosing of 25 oh vitamin d with postural balance in postmenopausal women with lumbar osteoporosis. one hundred and twenty-six postmenopausal women between 55-65 years of age were evaluated and separated into two groups according to the bone mineral density values of their lumbar spine: the osteoporosis group and the control group. functional mobility was evaluated through the timed up and go test. postural balance was evaluated using a accusway® model portable force platform, in standard standing position, with eyes open and closed, for 60". data were collected, stored, and processed by the balance clinic® program, configured to 100 hz frequency, with a frequency cut-off filter at 10 hz. muscle strength was evaluated via a biodex® isokinetic dynamometer in the concentric/concentric knee extension mode at 60o/s. dosing of 25 oh vitamin d and thoracic spine x-rays to determine the degree of kyphosis measured by the cobb angle were performed in the osteoporosis group.

Eligibility criteria:
inclusion criteria: * absence of impairment of the vestibular, proprioceptive, auditory or neurological system, and/or any mental disturbances or disorders; * no use of medications that might compromise postural balance; * absence of lesions, surgery or disease that might have caused lower-limb joint limitations over the previous six months; * absence of lower-limb dysmetria; * presence of clinically normal gait, without claudication. exclusion criteria: * the presence of pain or inability to complete any of the tests * along with occurrences of blood pressure increase before the strength evaluation.

Keywords: postural balance osteoporosis postmenopause vitamin d kyfhosis muscle strength
relationship of serum zinc level with severity of diabetic nephropathy

Conditions: Diabetic Nephropathy Type 2

Summary: zinc influences the production and action of erythropoietin (epo), a hormone produced by the kidneys that stimulates red blood cell production. however, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in patient with diabetic kidney disease. this study aim to detect serum zinc level in patient with diabetic kidney disease "ckd" and study of association between serum zinc and serum urea, creatinine, gfr, hemoglobin ,hba1c in dkd

chronic kidney disease (ckd) is an irreversible , progressive disease with high morbidity and mortality that occurs commonly in the general adult population, especially in people with diabetes and hypertension . it's defined as decreased kidney function shown by glomerular filtration rate (gfr) of less than 60 ml/min per 1·73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause . diabetic kidney disease represents the most common cause of ckd in developed countries. approximately 30% to 40% of diabetes mellitus (dm) subjects develop diabetic kidney disease "dkd", and its presence significantly increases the risk for morbidity and mortality. zinc is an essential element and is the second most abundant divalent cation in the human body (2-4 g). it is mainly distributed in skeletal muscles (57%) and bone (29%) and acts as a cofactor for more than 300 enzymes. in addition, zinc is involved in the cellular mechanisms of proliferation, maintenance of structural integrity, and in the systemic regulation of the immune system . zinc seems to have a potential role in kidney and body homeostasis in diabetic individuals which include stabilization of insulin hexamers and pancreatic insulin storage and improved glycemic control. decreased zinc levels can impair insulin function and glucose metabolism, potentially worsening diabetes control and increasing the risk of kidney damage. zinc is important for maintaining endothelial cell integrity and function. endothelial dysfunction is a hallmark of dkd, and decreased zinc levels can exacerbate vascular complications associated with diabetes. lower serum zinc levels have been associated with increased proteinuria, a common symptom of dkd. proteinuria indicates kidney damage and is a predictor of disease progression. zinc is involved in modulating the immune response. deficiency can lead to a heightened inflammatory state, exacerbating kidney damage. several studies underline the critical role of zinc in reducing oxidative stress levels, which is considered the common denominator of the mechanisms responsible for the progression of kidney disease. zinc is a cofactor for various enzymes involved in heme synthesis and erythropoiesis

Eligibility criteria:
inclusion criteria: * patients with diabetic kidney disease exclusion criteria: * patients on dialysis. patient refuse to participate * other renal disease "lupus nephritis,glomerulonephritis

Keywords: serum zinc level
glucose to goal: a model to support diabetes management in primary care

Conditions: Diabetes Mellitus

Summary: diabetes education is a very important part of diabetes care. most people with diabetes receive care in primary care practices where diabetes education is not always available. this project tests a model designed to improve access to diabetes education services.

evidence that diabetes self-management education (dsme) can improve health outcomes has repeatedly been shown and is considered to be a critical component of care. diabetes educators are highly skilled at addressing diabetes-related clinical and behavioral needs through dsme, but engagement with diabetes educators is underutilized. it has been suggested that poor referral practices and the way in which dsme service is delivered are the problems. most patients receive diabetes care in primary care yet most dsme programs are distinctly separate from primary care practice. this limits care coordination and diabetes educator access to amenities currently available to primary care. efforts are underway to change the us health care paradigm with a focus on quality in primary care that includes practice redesign, population management, and communication through electronic medical records. the purpose of this application is to evaluate the deployment of glucose to goal, a model relying on a systematic redesign of practice that links diabetes educators services with primary care. this will be compared to the traditional process for dsme delivery, without the direct connection to primary care processes, for an eighteen month period. the hypothesis is that the proportion of primary care provider referrals and patient utilization of diabetes educator services from primary care practices participating in glucose to goal will be higher compared to those associated with traditional dsme. it is anticipated that this model will appeal to primary care providers, demonstrate a feasible approach to offering diabetes education in the current health environment, and set the stage for future testing of the model, namely its impact on meaningful improvements on diabetes outcomes and cost-effectiveness.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * patients referred to diabetes self-management education by their primary care provider * able to read and write english exclusion criteria: * clinical diagnosis of type 1 or gestational diabetes * unable to speak or read english

Keywords: diabetes education chronic disease management health care delivery patient-centered medical home primary care
screening and intervention reducing anxiety in patients with cardiac disease

Conditions: Cognitive Therapy; Anxiety Disorders; Heart Diseases

Summary: the hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention. the aim of heart \& mind trial is (i) to determine the type of anxiety in cardiac patients and (ii) to investigate the effect of individual cognitive behavioural therapeutic intervention to reduce anxiety in patients with cardiac disease and anxiety compared to usual care.

the heart \& mind trial is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including four university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone. the intervention: all patients receive usual care. patients in the intervention group will receive an intervention based on cognitive behavioral therapy. the intervention consists of three steps: (1) screening of hospitalised and outpatient cardiac patients at four university hospitals using the hospital anxiety and depression scale (hads), scores ≥8 are invited to participate. (2) assessment of type of anxiety by structured clinical interview for dsm disorders (scid). (3) investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (cbt) performed by a cardiac nurse with (cbt) training, plus usual care or usual care alone.

Eligibility criteria:
inclusion criteria: * patients must be ≥18 years * diagnosed with cardiac disease * speak and understand danish * score ≥8 on the hospital anxiety and depression scale - anxiety (hads-a) * hads-a score must exceed the hads-d score * gives written informed consent.

Keywords: cognitive therapy anxiety heart diseases
eltrombopag and romiplostim used alternatively in patients with immune thrombopenia (itp): efficacy and safety.

Conditions: Immune Thrombocytopenia; Thrombopoietin Receptor Agonist

Summary: tpo-r switch is a retrospective study of the patients affected by immune thrombopenia (itp) who received alternatively romiplostim and eltrombopag.

thrombopoietin mimetics agents are available since 5 years in france through clinical trials first and then after their license. two drugs are used: romiplostim and eltrombopag. these molecules have the same receptor on the megacaryocyte and induce the same stimulation of this cell leading to the differentiation and the proliferation into platelets. but romiplostim and eltrombopag have 2 different characteristics: the way of administration (oral for eltrombopag and subcutaneous for romiplostim) and the binding site to the c-mpl receptor on megacaryocyte. the aim of this study is to describe itp patients who received these two drugs alternatively in order to know if there is a benefit for switching these molecules in clinical practice.

Eligibility criteria:
inclusion criteria: * subject has a diagnosis of itp according to the american society of hematology guidelines (rodeghiero et al, 2009). * subject is equal to or greater than 18 years of age. * before any study-specific procedure, the appropriate written informed consent must be obtained. * subject receiving romiplostim and eltrombopag alternatively * available follow-up of 2 months at least for each period exclusion criteria: - secondary itp e.g: thrombopenia related to hepatitis c, hiv, chronic lymphocytic leukemia

Keywords: immune thrombocytopenia thrombopoietin receptor agonist
extension study of protocol dfa102 to examine the long-term safety, tolerability, and effect on body weight of pramlintide administered in combination with metreleptin

Conditions: Obesity

Summary: study dfa102e is an extension of study dfa102, which included a 28-week treatment period with randomized study medication. the purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (sc) injections, in obese and overweight subjects.


Eligibility criteria:
inclusion criteria: * completed study dfa102, including all procedures required at the study termination visit, without major protocol deviations * male, or female and meets all the following criteria: 1. has a negative urine pregnancy test result at study start(not applicable to hysterectomized females) 2. if of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study * able to read, understand, and sign the informed consent form (icf) and if applicable,an authorization to use and disclose protected health information form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements exclusion criteria: * is expected to require or undergo treatment with any exclusionary medication. * is undesirable as a study participant as judged by the investigator

Keywords: leptin pramlintide obese symlin amylin
short course radiotherapy, unresectable rectal cancer, liver metastasis

Conditions: Rectal Cancer, Metastatic

Summary: the purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.


Eligibility criteria:
inclusion criteria: * pathologically confirmed for unresectable (impossible to try total mesorectal excision) rectal cancer with liver metastasis * over 19 years * eastern cooperative oncology group 0-1 * proper organ function * more than one target lesion (standard by response evaluation criteria in solid tumors 1.1) * who should sign on the informed consent form before participate the trial. exclusion criteria: * metastasis in other organ except liver * chronic active hepatitis or cirrhosis * history of treatment for metastatic colorectal cancer * subject pregnant or breast feeding * uncontrolled disease * have had adjuvant therapy * uncontrolled peripheral nerve infection * alcoholic or drug addict * subject currently is enrolled in or ≤30 days from ending other clinical trial. * history of other type of cancer except resolved from skin cancer and cervical cancer.
companion robotic pets and older adults

Conditions: Dementia; Social Behavior; Caregiver Burden

Summary: this research will assess the effect of companion robotic pets on the wellbeing of older adults and their family caregivers.

social robot pets have been shown to have a positive impact on age-related physical, cognitive, emotional, and social challenges that affect independence and quality of life. these "pets" are designed to interact with people as a real pet might. they purr when stroked, make eye contact, have a heartbeat, turn toward a person when touched, are warm, and appear lifelike. does introduction of such a pet reduce loneliness or promote engagement in older adults with cognitive or physical disability? this research will determine if: 1. older adults with disabilities engage with such robotic companions; 2. placing a robotic pet in a home enhances mood and positive affect in older people; 3. caregivers to these adults find the robots beneficial for their own mood and time use. in a single-blind randomized controlled trial over 6-8 weeks, we hypothesize that older adults in the intervention arm will engage with the pets and show benefit in mood as reported by family caregivers.

Eligibility criteria:
inclusion criteria: 1. participating in family caregiver support program or options program administered by allegheny county area agency on aging 2. provide unpaid family or friend caregiver support for at least 6 months 3. older person aged 50+ 4. able to provide verbal informed consent exclusion criteria: 1. uncomfortable with robot pet companion in home 2. family caregiver \< 18 years age